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/Samsung Bioepis

Samsung Bioepis, which has spearheaded the biosimilar market, is poised to accelerate its U.S. Food and Drug Administration (FDA) approval timeline with its first independently developed novel drug pipeline.

Samsung Bioepis announced on the 21st that its novel anticancer drug candidate, SBE303, has been granted Fast Track designation by the U.S. FDA.

SBE303 is an antibody-drug conjugate (ADC) targeting Nectin-4, a protein overexpressed on cancer cells, and marks the first novel drug pipeline developed by Samsung Bioepis.

This Fast Track designation targets the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received Nectin-4-directed therapy.

The U.S. FDA's Fast Track designation is designed to identify and expedite new drug candidates that have demonstrated efficacy in early animal studies or clinical tests and address serious conditions with unmet medical needs.

A primary advantage of Fast Track designation is expanded opportunities for direct communication with regulatory authorities. From the early stages of SBE303's development, Samsung Bioepis secures opportunities for sophisticated risk management and streamlined regulatory processes.

Jung Byung-in, head of the Regulatory Affairs (RA) Team and vice president at Samsung Bioepis, said, "The U.S. FDA's Fast Track designation reflects recognition of SBE303's potential to address unmet medical needs in serious diseases." He added, "Through this, Samsung Bioepis proves that it possesses world-class R&D capabilities in novel drug development as well."

                                                                                                        Moon Jeong-woo